Audit and Inspection Coordinator - VIE Contract (W/M)

Audit and Inspection Coordinator - VIE Contract (W/M)

Sanofi | Amsterdam, NY, 12010, US

Posted 12 days ago

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Description

iMove, the Sanofi VIE Program, is available to citizens of the European Economic Area (EU + Norway, Liechtenstein and Iceland) aged between 18 and 28.

PLEASE NOTE that since this program is primarily an international development program, candidates cannot apply to a VIE assignment in their own country of citizenship.

PLEASE NOTE that applications that are only submitted in French cannot be considered by our non-French speaking partners at Sanofi worldwide.

Therefore, only applications that are submitted in English will be considered.

At Sanofi diversity and inclusion is foundational to how we operate and is embedded in our Core Values. We respect the diversity of our people, their backgrounds and experiences. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our employees, patients and customers.

We are looking for: Audit and Inspection Coordinator - VIE Contract (W/M)

Target start date: 01/021/2023

Responsibilities:

* Providing quality inputs on tools, processes and activities in place in all regions to allow a consistent quality oversight of the Pharmacovigilance (PV) activities
* Contribute to deliver Quarterly Quality Report for Quality Forum, Audit Inspection PV Governance Meeting (AIPG) and Global PV reports and monthly reports
* Contribute to the development of a risk-based profile grid for country quality PV system to assess situation of the International network
* Support the management of Business Partners audits
* Support implementation of recommendations to enhance country PV systems in accordance with global processes
* Support in the preparation of country office audits and inspections, definition of root-cause analysis and Corrective & Preventive Actions (CAPA) follow-up
* Support country office to pull Individual Case Safety Report (ICSR) compliance data at time of audits and for routine monitoring. Work with PV Compliance team to identify missing investigations and / or trends related to local ICSR Compliance
* Provide analysis of PV findings trends across regions
* Provide support for the maintenance of the Pharmacovigilance System Master File (PSMF)
* Support compliance of quality documents with local regulations and procedures
* Engage in development and implementation of training materials related to process improvement initiatives
* Contribute to joint projects between Audit and inspection readiness team and PV compliance team

Requirements:

* Pharmaceutical Degree or Master's Degree in Human Health Sciences
* Experience in Pharmacovigilance / Medical Affairs / Regulatory Affairs or Quality Assurance
* Understanding of Pharmacovigilance regulatory requirements
* Experience in CAPA (Corrective and Preventive Actions) management
* Knowledge of MS office (proficient use of Excel and PowerPoint)
* Fluent in English verbal and written
* Tech-savvy
* Able to work transversally
* Goal oriented
* Good interpersonal communication and networking skills
* Dependability, independent yet willing to incorporate feedback
* Ability to network with key stakeholders
* Organized and detail oriented
* Efficient at time management
* Analytic thinker
* Quick learner
* Effective problem-solving skills

At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.